e who discontinued due to an adverse event, subject withdrawal or were lost to follow-up, were counted as SVR12 failures.
Demographics and Baseline Characteristics of Clinical Trials in Treatment-Naïve or Treatment-Experienced Adults to PegInterferon, Ribavirin and/or Sofosbuvir (PRS)Without Cirrhosis or With Compensated Cirrhosis (Child-Pugh A)
Of the 2,152 treated subjects without cirrhosis or with compensated cirrhosis who were treatment-naïve or treatment-experienced to a combination of interferon, peginterferon, ribavirin and/or sofosbuvir (PRS), excluding EXPEDITION-4 and MAGELLAN-1, the median age was 54 years (range: 19 to 88); 73% were treatment-naïve, 27% were PRS treatment-experienced; 39% were HCV genotype 1; 21% were HCV genotype 2; 29% were HCV genotype 3; 7% were HCV genotype 4; 4% were HCV genotype 5-6; 13% were ≥65 years; 54% were male; 5% were Black; 12% had cirrhosis; 20% had a body mass index of at least 30 kg per m2; and median baseline HCV RNA level was 6.2 log10 IU/mL.
14.2 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 1, 2, 4, 5, or 6 Infection Without Cirrhosis
The efficacy of MAVYRET in subjects who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir (PRS) with genotype 1, 2, 4, 5 or 6 chronic HCV infection without cirrhosis was studied in four trials using 8- or 12-week durations: ENDURANCE-1, ENDURANCE-4, SURVEYOR-1 (Part 2), and SURVEYOR-2 (Part 2 and Part 4).
ENDURANCE-1 was a randomized (1:1), open-label, multi-national trial comparing the efficacy of 8 weeks of treatment with MAVYRET versus 12 weeks of treatment in subjects without cirrhosis with genotype 1 infection with or without HIV-1 co-infection (n=33 co-infected). Table 11 presents SVR12 in MAVYRET-treated genotype 1 infected subjects for the 8 week treatment arm. Due to numerically similar efficacy, MAVYRET is recommended for 8 weeks for treatment-naïve and PRS treatment-experienced genotype 1 subjects without cirrhosis, rather than 12 weeks [see Dosage and Administration (2.2)].
Table 11. ENDURANCE-1: Efficacy in Treatment-Naïve and PRS Treatment-Experienced With HCV Genotype 1 Infection and Without Cirrhosis
Genotype 1
MAVYRET
8 Weeks
(N=351)
SVR12 99% (348/351)
Outcome for Subjects Without SVR12
On-treatment VF <1% (1/351)
Relapse 0/349
Other* <1% (2/351)
VF= virologic failure
* Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
The SVR12 data from the open-label trials SURVEYOR-2 (Parts 2 and 4), ENDURANCE-4 and SURVEYOR-1 (Part 2) are pooled by genotype, where appropriate, in TABLE 12 for ease of display.
Table 12. SURVEYOR-2 (Part 2 and Part 4), ENDURANCE-4 and SURVEYOR-1 (Part 2): Efficacy in Treatment-Naïve and PRS Treatment-Experienced Adults With HCV Genotypes 2, 4, 5 or 6 Infection Without Cirrhosis
SURVEYOR-2
MAVYRET
8 Weeks ENDURANCE-4
and SURVEYOR-1
MAVYRET
12 Weeks
GT2
N=197 GT4
N=46 GT5
N=2 GT6
N=10 GT5
N=27 GT6
N=30
SVR 12 98%
(193/197) 93%
(43/46) 100%
(2/2) 100%
(10/10) 100%
(27/27) 100%
(30/30)
Outcome for Subjects Without SVR12
On Treatment VF 0/197&n |
